On-the-ground application of the 'temporary recommendation for use' regulatory measure on off-label use of baclofen for alcohol dependence in France: a regional survey of community pharmacies.
Fundam Clin Pharmacol
; 32(2): 234-238, 2018 Apr.
Article
em En
| MEDLINE
| ID: mdl-29143356
ABSTRACT
The 'temporary recommendation for use' (TRU) is a French novel regulatory measure for off-label drug. The first TRU to be issued by the French drug agency (in March 2014) pertained to the off-label use of baclofen for alcohol dependence (AD). We performed a questionnaire-based survey of the on-the-ground application of the baclofen TRU among community pharmacies in northern France. A pharmacist from 70 of the 219 pharmacies contacted (response rate 32.0%) completed the questionnaire. The mean ± standard deviation number of off-label baclofen prescriptions for AD was 2.3 ± 2.2 per pharmacy per month. 65.2% of these prescriptions were issued by primary care physicians. 65.7% of the pharmacists had never seen 'TRU' written on the prescription, and 80.3% delivered a prescription without checking whether the patient had been included by the prescriber in the TRU. The main criterion used to identify off-label prescribing was the patient's medical history (according to 74.6% of pharmacists) and the prescription of an above-threshold dose (73.1%). 87.1% of the pharmacists were aware of the baclofen TRU, and 42.9% had actually read the document. 17.9% of the pharmacists estimated that the TRU had changed their attitude to off-label baclofen prescription, and 29.9% (20 out of 67) of them wanted to be more involved in the TRU process. Community pharmacists were well informed about the off-label use of baclofen for AD and the TRU. However, a majority of baclofen prescribers did not fulfill the TRU requirements while a majority of pharmacists did not exert any control over these off-label prescriptions. In practice, in 2015 the TRU measure had thus a limited impact on both the baclofen prescribing and delivery practices.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Baclofeno
/
Serviços Comunitários de Farmácia
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Controle de Medicamentos e Entorpecentes
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Alcoolismo
/
Uso Off-Label
/
Agonistas dos Receptores de GABA-B
Tipo de estudo:
Diagnostic_studies
/
Evaluation_studies
/
Guideline
/
Prognostic_studies
/
Qualitative_research
Limite:
Humans
País/Região como assunto:
Europa
Idioma:
En
Revista:
Fundam Clin Pharmacol
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
França